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the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs (CTC-TCM-FZ)

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ClinicalTrials.gov Identifier: NCT02603003
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
jianhuitian, Shanghai University of Traditional Chinese Medicine

Brief Summary:
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer(NSCLC) Drug: JinFuKang Drug: Cisplatin Drug: Pemetrexed Phase 1

Detailed Description:
Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation
Study Start Date : June 2015
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Pemetrexed

Arm Intervention/treatment
Placebo Comparator: Cisplatin
Cisplatin
Drug: Cisplatin
According to the individual patient's condition
Other Name: Navelbine

Placebo Comparator: Pemetrexed
Pemetrexed
Drug: Pemetrexed
According to the individual patient's condition
Other Name: Pemetrexeddisodium for Injection

Experimental: Jinfukang
Jinfukang
Drug: JinFuKang
po.tid.30ml
Other Name: Jin Fukang oral liquid

Drug: Cisplatin
According to the individual patient's condition
Other Name: Navelbine

Drug: Pemetrexed
According to the individual patient's condition
Other Name: Pemetrexeddisodium for Injection




Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: The progression disease is assessed based on CT or PET-CT every six months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer,assessed up to Two years. ]
    It is decided by a doctor via the clinical examinations


Secondary Outcome Measures :
  1. Circulating Tumor Cell [ Time Frame: 24months ]
    It is decided by a doctor via the clinical examinations

  2. Overall survival [ Time Frame: Two years ]
    It is decided by a doctor via the clinical examinations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
  2. Patients receiving chemotherapy for the first time in 6 weeks after surgery;
  3. Age from 18 Years to 70 Years;
  4. The liver and renal function were normal,and no other disease.
  5. Patients compliance is good ang can understand the situation of this study and signed informed consent

Exclusion Criteria:

  1. Patients without clear pathological diagnosis;
  2. The expected survival period is morn than 6 months;
  3. Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
  4. Patients with pregnancy or lactation;
  5. Persons with a history of less control.
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Responsible Party: jianhuitian, Clinical Professor, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02603003    
Other Study ID Numbers: Longhua Hospital
TJH20151021 ( Registry Identifier: TIAN Jianhui )
LB20151106 ( Registry Identifier: Robin )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Keywords provided by jianhuitian, Shanghai University of Traditional Chinese Medicine:
Circulating tumor cells(CTCs)
Traditional Chinese Medicine(TCM)
Myeloid-derived suppressor cells(MDSCs)
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors